Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT06113432
Eligibility Criteria:
Inclusion Criteria:
* Patients with acute hypoxemic respiratory failure due to community-acquired pneumonia or COVID-19
* The ratio of the partial pressure of oxygen in arterial blood to the inspiratory fraction of oxygen (PaO2/FiO2) is less than 250 mm Hg while breathing atmospheric air
* Respiratory rate more than \> 25 per minute.
* Written informed consent
Exclusion Criteria:
* Patients who achieve the following target parameters with only low-flow oxygen therapy (flow up to 15 l/min): SpO2 \> 93%, the patient does not have a subjective feeling of fatigue, there is no visible work of the auxiliary respiratory muscles of the neck,
* Unstable hemodynamics (systolic blood pressure \<90 mm Hg or mean arterial pressure \<65 mm Hg) and/or lactic acidosis (lactate \>5 mmol/l and/or clinically diagnosed shock) and/or life-threatening arrhythmia,
* Metabolic acidosis (pH \<7.30);
* Patients who were in the ICU for less than 24 hours for any reason
* Primary or secondary lung diseases (exacerbation of chronic obstructive pulmonary disease (COPD), bronchial asthma, interstitial lung diseases, metastatic lung disease)
* Cardiogenic pulmonary edema,
* Chronic diseases in the stag e of decompensation with the development of extrapulmonary organ dysfunction (liver cirrhosis, progression of cancer, CHF),
* Glasgow Coma Scale score \<14 points,
* Swallowing disorders
* Hypercapnia (PaCO2\>45 mmHg),
* The need for urgent tracheal intubation for any reason,
* Recent head surgery or anatomy that prevents the placement of a helmet or full face mask on the patient,
* Pregnancy,
* Inability to cooperate with staff
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06113432
Study Brief:
Protocol Section:
NCT06113432